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QA - MES, DeltaV HBV at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

21 Sep, 26

Salary

0.0

Posted On

23 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

MES, DeltaV, HBV, Validation Protocols, IQ/OQ/PQ, GAMP 5, 21 CFR Part 11, Annex 11, CSV, Functional Testing, Integration Testing, Regression Testing, Change Control, Commissioning, Pharma 4.0, Digital Transformation

Industry

Pharmaceutical Manufacturing

Description

QA Engineer – MES, DeltaV, HBV Key Responsibilities & Requirements: Ensure quality oversight of MES, DeltaV, and HBV systems in pharma manufacturing. Develop and execute validation protocols (IQ/OQ/PQ) in compliance with GAMP 5, 21 CFR Part 11, Annex 11. Perform functional, integration, and regression testing for MES workflows and DeltaV batch configurations. Review and approve CSV documentation including test scripts, deviations, and change controls. Support commissioning and qualification of DeltaV hardware/software and HBV systems. Collaborate with automation, process, and QA teams to resolve system issues. Ensure audit readiness by maintaining validation records and compliance reports. Drive paperless validation initiatives and digital transformation (Pharma 4.0). Provide QA input during system upgrades, patches, and migrations.

Responsibilities

Provide quality oversight for MES, DeltaV, and HBV systems within a pharmaceutical manufacturing environment. Develop and execute validation protocols while ensuring compliance with regulatory standards and driving digital transformation initiatives.